ISRCTN11114726已完成不适用

A randomised, open-label phase III study of first line chemotherapy in older metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine, and the incorporation of a complete geriatric assessment

Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG]) (The Netherlands)0 个研究点目标入组 154 人开始时间: 2007年3月7日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Female patients with metastatic breast cancer, being eligible for first line chemotherapy
•2. Aged greater than 65 years
•3. Non-measurable (evaluable) or measurable disease (according to Response Evaluation Criteria in Solid Tumours [RECIST] criteria). In case of evaluable (non-measurable) disease, the presence of an increased tumour marker (either Cancer antigen 15.3 [Ca15.3], Cancer antigen-125 [Ca125], Carcinoembryonic Antigen [CEA], whatever is increased) is obligatory
•4. European Cooperative Oncology Group (ECOG) performance score of zero to two
•5. May be Human Epidermal growth factor Receptor 2 (HER-2/neu) positive or negative
•6. Adequate bone marrow function, acceptable renal function and acceptable liver functions
•7. Normal baseline Left Ventricular Ejection Fraction (LVEF) by Multiple Gated Acquisition (MUGA) scan according to the institutional limits, no prior history of myocardial infarction within less than six months, no cardiac insufficiency (New York Heart Association [NYHA] Class II or greater), no clinical evidence of Congestive Heart Failure (CHF) or Myocardial Infarction (MI) within less than six months
•8. Written informed consent
•9. Patients being willing and able to complete study questionnaires in the Dutch language

•1. No anthracyclin-resistant disease (defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse within 12 months after completion of anthracycline therapy) and adjuvant cumulative anthracycline dose (if given in the adjuvant setting) of less than 240 mg/m^2 of doxorubicin (or less than 450 mg/m^2 of epirubicin)
•2. Evidence of Metastatic Breast Cancer (MBC) in the central nervous system, unless previously treated and being asymptomatic/controlled for at least three months
•3. No current or previous chemotherapy for metastatic breast cancer (unless received in the adjuvant setting); patient may also have received hormonal and/or trastuzumab therapy for metastatic disease, as long as this therapy has been stopped for over two weeks)
•4. No other malignancy within the previous five years (except adequately treated in situ carcinoma of cervix, or basal cell carcinoma)
•5. No abuse of drugs, alcohol, pharmaceuticals, competing with adequate compliance in this study

发起方

Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG]) (The Netherlands)